Efficacy of Shoulder Mobilisation Versus Conventional Immobilisation for Nonsurgically Proximal Humerus Fracture

Assistance Publique - Hôpitaux de Paris

Status and phase: Terminated; Phase 3

Conditions: Shoulder Fracture

Treatments: Procedure: mobilisation (rehabilitation)

Study type: Interventional

Funder types: Other

Identifiers

NCT00326794

P011022

Details and patient eligibility

About

Background: Nonsurgical proximal humerus fracture is common, causing prolonged disability, for which the time to begin rehabilitation is not well determined. We assessed the feasibility and efficacy of early (within 3 days'after fracture) mobilisation of the shoulder compared with conventional 3-week immobilization followed by physiotherapy.

Full description

Methods: We randomly assigned 74 patients with impacted nonsurgically treated proximal humerus fracture to receive early passive mobilisation or conventional-treatment. The primary outcome was functional assessment of the shoulder (Constant score) at 3 months. Secondary outcomes were functional assessment at 6 weeks and at 6 months, change in pain (on a visual analogue scale) and passive range of motion.

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Impacted nonsurgically treated proximal humerus fracture
• Patients over the age 20

Exclusion criteria

• Pre-existing shoulder pathology
• Neurological disorders of the upper limbs
• Indication for surgery of the shoulder
• Combined polytrauma
• Difficulties with language or comprehension to understand a rehabilitation program and information

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind